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Smile Makers Come Connected 22.07.0018

by Ramblin Brands USA LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04897041441673 UDI-DI Date13 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Smile Makers Come Connected
Generic Name
Basic male condom, Hevea-latex
Model / Reference
22.07.0018
Primary DI / UDI-DI
04897041441673
FDA Product Code
HIS
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class II
Regulation Number
884.5300
GUDID distribution status
In Commercial Distribution

Properties

  • Single Use
  • Contains Latex
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No